A dose-ranging study of a methylphenidate transdermal system in children with ADHD
Objective: This was a multicenter, double-blind, randomized, dose-ranging study of a methylphenidate (MPH) transdermal system (MTS). Medication (placebo, 0.45, 0.9, and 1.8 mg/h) was crossed with application time (6 a.m., 7 a.m.) to evaluate MTS efficacy and influence of exposure time on morning effects. Method: The study took place in a summer treatment program (STP) at three sites, with 36 children aged 7-12 years with attention-deficit/hyperactivity disorder. Each treatment was administered for 1 day in random order, for a total of 8 days. Behavioral and academic measures were taken as well as patch wear characteristics and side effects. Results: Evaluable participant data were analyzed in a series of dose x application time multivariate analyses of variance. All MTS conditions were significantly different from placebo across measures. Time of application had no significant effect on daily behavior, and effects of application time on morning behavior were inconclusive. Consistent with previous results in this setting, the highest dose produced limited incremental benefit compared with the mid-range dose. The wear characteristics of the MTS were acceptable, and the formulation was well tolerated. Conclusions: The MTS produced significant effects that were similar to those previously reported with comparable MPH doses. There does not appear to be a substantial effect of application time on total daily functioning in this setting, further controlled time-course studies will be necessary to evaluate the question of morning onset fully. Â©2005 Journal of the American Academy of Child and Adolescent Psychiatry.
Journal of the American Academy of Child and Adolescent Psychiatry
Pelham Jr., W. E.; Manos, M. J.; Ezzell, C. E.; Tresco, Katy E.; Gnagy, E. M.; Hoffman, M. T.; Onyango, A. N.; Fabiano, G. A.; Tresco, Katy E.; and et al., "A dose-ranging study of a methylphenidate transdermal system in children with ADHD" (2005). PCOM Scholarly Papers. 818.
This article was published in Journal of the American Academy of Child and Adolescent Psychiatry, Volume 44, Issue 6, Pages 522-529.The published version is available at http://dx.doi.org/10.1097/01.chi.0000157548.48960.95.
Copyright © 2005 AACAP.